Banner

Critical and Advanced Intermediates

Starting Materials

  • We can assist you in selecting starting materials considering the current regulatory requirements while optimizing costs.
  • We can plan with you a regulatory strategy to support your chosen starting material.
  • Documentation for “critical” starting materials can be prepared in case these become GMP Intermediates.

GMP Intermediates

By introducing a “backwards integration” solution package, we can help you in meeting stricter requirements for starting materials. Our services include:

  • Supplier evaluation and qualification
  • Compilation of regulatory documentation
  • Regulatory support during registration and variation procedures.

N-1 Intermediates

We offer cost-effective solutions via N-1 intermediates produced under GMP for APIs under price pressure. Our services include those listed above under GMP Intermediates.

Chiral Intermediates

Midas enables access to chiral intermediates via either chemical or enzymatic catalysis.

Controlled Substances

Our proven track record rests upon broad experience and a range of narcotic intermediates for pharmaceutical applications. We comply with all regulations for narcotic and psychotropic substances, as well as precursors (scheduled substances "GüG"). We manage cross-border handling of controlled substances to meet your requirements.

Complementary Services

Custom Synthesis Services — for non-sourceable and hard to find APIs/IMs, our experts can tailor a synthesis that satisfies any technological requirement. More

Intellectual Property Services — assure the successful course of proprietary development projects. They evaluate the intellectual property (IP) situation of Routes of Synthesis (RoS), clarify the legal status of EP patents (EPO), and do freedom to operate analysis (FTO) and associated reports. More

Quality Management Services — assess supplier and sites qualifications supporting all quality questions regarding GMP and N-1 intermediates. More

Regulatory Services — compile regulatory documentation required for GMP and N-1 Intermediates and provide crucial assistance during registration procedures. More

We support your project to prevent common pitfalls while enabling enduring success:

EDQM obtained 90 CEP applications in 2011. In the first attempt, 88 out of 90 failed due to deficiencies related to starting materials and key intermediate issues. More

With a wealth of experience and expertise in sourcing and supplying intermediates, as well as providing related services, we offer comprehensive solutions to meet your needs.

Please contact:
Dr. Peter Markus
This email address is being protected from spambots. You need JavaScript enabled to view it.
Diese Website verwendet Cookies. Cookies sind kleine Textdateien, die dabei helfen, die Website zu optimieren. Mit der Nutzung der Website stimmen Sie der Verwendung von Cookies zu. Nähere Informationen zu Cookies finden Sie in unserer Datenschutzerklärung.
This website uses cookies. Cookies are small text files which help us to optimize this website. By using this website you agree to the use of cookies. More information concerning cookies is available in the privacy statement.